Suction evacuation device

ABSTRACT

A method for removing a stone from a patient comprising the steps of: providing a suction evacuation assembly which includes a sheath and one or more side arms; inserting and positioning a distal end of the sheath into a lumen or cavity of a patient&#39;s body containing a stones; connecting a tube to one of the side arms and to a collection bottle; connecting another tube to the collection bottle and a negative pressure system; visualizing the stone or foreign body using a scope inserted through the assembly; activating the negative pressure system in order to remove the stone from the cavity if the diameter of the stone is narrower than an inside diameter of the sheath and the side arm, or performing a lithotripsy on the stone to create fragments with a decreased diameter which allow the passage through the assembly; and collecting the stone in the collection bottle.

RELATED CASES

This is a divisional application of U.S. patent application Ser. No.14/341,905 filed on Jul. 28, 2014. The full disclosure of thatapplication is expressly incorporated herein by reference.

FIELD OF THE INVENTION

A surgical device used to retrieve stones from a patient's body isdisclosed herein below.

BACKGROUND OF THE INVENTION

Kidney stones and gallstones have plagued mankind for ages.Complications resulting from the presence of stones in the urinary tractor biliary tract often require surgical intervention to remedy theproblem. A patient will require several days in the hospital to recoverfrom a typical surgical procedure to remove a stone wherein a surgeonincises a patient's abdomen in order to remove the stone. The use ofless invasive stone retrieval devises has decreased the suffering andrecovery time required by a patient.

During the past 40 years great strides have been made in the treatmentof stone disease, especially in the field of extracorporeal andendoscopic lithotripsy. However, all the inventions focus on the accessand fragmentation of the stones. Extracorporeal shock wave lithotripsyuses pressure waves to crush the stone, but then requires the patient topass the stone fragments on their own. Amplatz percutaneous nephrostomysheaths and various ureteral sheaths allow access to the stones forlithotripsy. However, they require either the patient to pass the stonefragments on their own or to have the stone removed at the time oflithotripsy using pressure irrigation and/or stone forceps. Pressureirrigation and stone forceps tend to increase operative time as well assurgical complications.

While the stone retrieval devices known in the prior art performedadequately, there is significant room for improvement. The stoneretrieval device disclosed below is an improvement over those known inthe art.

SUMMARY OF THE INVENTION

A method for removing a stone from a patient comprising the steps of:providing a suction evacuation assembly which includes a sheath and oneor more side arms; inserting and positioning a distal end of the sheathinto a lumen or cavity of a patient's body containing a stones;connecting a tube to one of the side arms and to a collection bottle;connecting another tube to the collection bottle and a negative pressuresystem; visualizing the stone or foreign body using a scope insertedthrough the assembly; activating the negative pressure system in orderto remove the stone from the cavity if the diameter of the stone isnarrower than an inside diameter of the sheath and the side arm, orperforming a lithotripsy on the stone to create fragments with adecreased diameter which allow the passage through the assembly; andcollecting the stone in the collection bottle. The irrigation isgenerally provided through the endoscope; however, additional irrigationcan be added through the secondary side arm or arms.

Whereas this device was initially developed for the treatment of stonedisease; using the same principle, it soon becomes apparent that thisdevice is also applicable for the removal of a foreign body in the bodycavity or lumen and can be used for tissue ablation.

DESCRIPTION OF THE DRAWINGS

For the purpose of illustrating the invention, there is shown in thedrawings a form that is presently preferred; it being understood,however, that this invention is not limited to the precise arrangementsand instrumentalities shown.

FIG. 1 is a perspective view of one embodiment of the present invention.

FIG. 2 is a front view of one embodiment of the present invention.

FIG. 3 is a back view of one embodiment of the present invention.

FIG. 4 is a top-down view of one embodiment of the present invention.

FIG. 5 is a bottom-up view of one embodiment of the present invention.

FIG. 6 is a side view of one embodiment of the present invention.

FIG. 7 is a side view of one embodiment of the present invention.

FIG. 8 is a cut-through view of one embodiment of the present invention.

FIG. 9 is a cut-through view of one embodiment of the present invention.

FIG. 10 is a cut-through view of one embodiment of the presentinvention.

FIG. 11 is a perspective view of one embodiment of the presentinvention.

FIG. 12 is a front view of one embodiment of the present invention.

FIG. 13 is a back view of one embodiment of the present invention.

FIG. 14 is a top-down view of one embodiment of the present invention.

FIG. 15 is a bottom-up view of one embodiment of the present invention.

FIG. 16 is a perspective view of one embodiment of the presentinvention.

FIG. 17 is a perspective view of one embodiment of the presentinvention.

FIG. 18a is a side view of one embodiment of the present invention.

FIG. 18b is a cut-through view of one embodiment of the presentinvention.

FIG. 19a is a side view of one embodiment of the present invention.

FIG. 19b is a cut-through view of one embodiment of the presentinvention.

DESCRIPTION OF THE INVENTION

The current invention addresses numerous issues with the prior art andincludes access to the stone in addition to providing a means for theremoval of the stone fragments through negative pressure suction.Referring to the figures, where like numerals refer to like elements,there is shown a sheath 20 of the suction evacuation assembly 10 is tobe used for endoscopic lithotripsy and extraction of stone fragments.One important feature of the current invention is a sheath 20 that has aside arm 50 that has an identical or nearly identical luminalcircumference. The side arm 50 is connected a collection container 80which is connected to a negative pressure aspirator 120 (see FIGS. 10and 16). When stone fragments are smaller they can be evacuated throughthe sheath 20 in the space between the endoscope and the sheath 20. Whenthe stone fragments are larger, but still small enough to enter thesheath lumen 23, the endoscope can be withdrawn to a location that isjust proximal to the distal end 52 of the side arm 50. This location ismarked by a colored band that can be seen both externally and internally(through the scope). With the scope in this position, the sheath 20 andthe side arm lumens now have a similar caliber channel with the sideport channel equal or slightly larger than the sheath channel. The stonefragments or foreign body have an unimpeded evacuation route. Thisallows a continuous evacuation channel for the stone fragments to reachthe collection container 80. During the development of the devicedisclosed in the instant invention, it was found that the device couldalso be used to remove a foreign body from a patient's body cavity orlumen. Additionally, the device could also be used for tissue ablationand morcellation.

The present invention involves a method of using a suction evacuationassembly 10 for removing one or more stones or foreign bodies fromwithin a patient. The suction evacuation assembly includes a sheath 20,an obturator 90, a flexible cap 100, connecting tubing 70, andcollection container 80. More specifically, the present inventiondiscloses a method for removing a stone, a stone fragment or a foreignbody from a patient using a suction evacuation assembly 10 comprisingthe steps of:

(a) providing a suction evacuation assembly 10 which includes a sheath20 and one or more side arms 50;

(b) inserting an obturator 90 into a proximal end 21 of a sheath 20 andsecuring the obturator to the proximal end of the sheath the sheathbeing comprised of a proximal sheath 30 and a distal sheath 40, whereinthe proximal sheath 30 has a proximal end 31 and a distal end 32 and thedistal sheath 40 has a proximal end 41 and a distal end 42, wherein thedistal end 32 of the proximal sheath 30 is secured to the proximal end41 of the distal sheath 40 and wherein the proximal sheath 30 has one ormore side arms 50 emanating from the outer surface 34 of the proximalsheath, and wherein the sheath 20 has a lumen 23 which is the samediameter as a lumen 53 of the one or more side arms 50;

(c) inserting a distal end 22 of the sheath into a lumen or cavity of apatient's body containing one or more stones or foreign bodies;

(d) positioning the distal end to of the sheath in a position in closeproximity to the stones or foreign bodies;

(e) disengaging the obturator 90 from the proximal end 21 of the sheathand removing the obturator from the sheath 20;

(f) securing a flexible cap 100 to the proximal end of the sheath;

(g) connecting one end of a primary tube 76 to one of the side arms 50and connecting the other end of the primary tube 76 to a collectioncontainer 80;

(h) connecting one end of a secondary tube 78 to the collectioncontainer 80 and connecting the other end of the secondary tube 78 to anegative pressure system 120;

(i) inserting a scope into the sheath through the flexible cap and intothe patient;

(j) visualizing the stone or foreign body using the scope;

(k) activating the negative pressure system 120 in order to remove thestone or foreign body from the cavity if a diameter of the stone orforeign body is narrower than an inside diameter of the sheath lumen 23and the inside diameter of the side arm lumen 53, or

(l) performing a lithotripsy on the stone or the foreign body in orderto create fragments with a decreased diameter which allow the passage ofthe fragments between the endoscope and sheath lumen 23 or within theinside diameter of the sheath lumen 23 and the inside diameter of theside arm lumen 53 when the endoscope is withdrawn to the bifurcation(the color band 36); and

(m) collecting the stone, foreign body and/or fragments in thecollection container 80.

Methodology for Tissue Ablation and Morcellation

The present invention also involves a method of using a suctionevacuation assembly 10 for ablation and morcellation of tissue within apatient. The suction evacuation assembly includes a sheath 20, anobturator 90, a flexible cap 100, connecting tubing 70, and collectioncontainer 80. More specifically, the present invention discloses amethod for ablation and morcellation from a patient using a suctionevacuation assembly 10 comprising the steps of:

(a) providing a suction evacuation assembly 10 which includes a sheath20 and one or more side arms 50;

(b) inserting an obturator 90 into a proximal end 21 of a sheath 20 andsecuring the obturator to the proximal end of the sheath the sheathbeing comprised of a proximal sheath 30 and a distal sheath 40, whereinthe proximal sheath 30 has a proximal end 31 and a distal end 32 and thedistal sheath 40 has a proximal end 41 and a distal end 42, wherein thedistal end 32 of the proximal sheath 30 is secured to the proximal end41 of the distal sheath 40 and wherein the proximal sheath 30 has one ormore side arms 50 emanating from the outer surface 34 of the proximalsheath, and wherein the sheath 20 has a lumen 23 which is the samediameter as a lumen 53 of the one or more side arms 50;

(c) inserting a distal end 22 of the sheath 20 into a lumen or cavity ofa patient's body containing the target tissue or organ;

(d) positioning the distal end to of the sheath in a position in closeproximity to the tissue or organ;

(e) disengaging the obturator 90 from the proximal end 21 of the sheathand removing the obturator from the sheath 20;

(f) securing a flexible cap 100 to the proximal end of the sheath;

(g) connecting one end of a primary tube 76 to one of the side arms 50and connecting the other end of the primary tube 76 to a collectioncontainer 80;

(h) connecting one end of a secondary tube 78 to the collectioncontainer 80 and connecting the other end of the secondary tube 78 to anegative pressure system 120;

(i) inserting a scope into the sheath through the flexible cap and intothe patient;

(j) visualizing the target tissue or organ using the scope;

(k) activating the negative pressure system 120 in order to remove thetissue fragments.

(l) performing tissue ablation using thermal energy or morcellation oftissue using mechanical or thermal energy in order to create fragmentswith a decreased diameter which allow the passage of the fragmentsbetween the endoscope and sheath lumen 23 or within the inside diameterof the sheath lumen 23 and the inside diameter of the side arm lumen 53when the endoscope is withdrawn to the bifurcation (the color band 36);and

(m) collecting tissue fragments in the collection container 80.

Irrigation is normally provided through the endoscope during the aboveprocess, however, additional irrigation can be added through thesecondary side arm 60 or arms.

Sheath 20, as used herein, refers to a rigid, semi-rigid, or flexibletube. The sheath 20 can be constructed from any medical grade materialincluding, but not limited to, nylon, polyethylene, polyvinyl chloride,polycarbonate, polypropylene, or fluorinated ethylene propylene. Thesheath 20 may be reinforced with a rigid or a semi-rigid coil orfilaments within its wall to add additional rigidity if desired. In oneembodiment of the present invention, the sheath 20 is reinforced withradiopaque material. In another embodiment of the present invention, thesheath 20 may further include one or more radiopaque materials. Thesheath 20 has a proximal end 21 through which instruments may beinserted and withdrawn. The sheath 20 has a distal end 22 which isinserted into a patient. The sheath 20 also has a lumen 23 and an outersurface 24. In one embodiment of the present invention, illustrated inFIGS. 1-10, the sheath 20 is comprised of a proximal sheath 30 and adistal sheath 40 in respect to the operator holding the device. The twosheaths (i.e., a proximal sheath and a distal sheath) can be joinedtogether as a single piece or can be joined together in a sleeve typeconnection. The length of the sheath 20 may correspond to any lengthknown in the art. In one embodiment, the length of the sheath is in therange of 15 to 45 cm. The lumen 23 of the sheath may be any diameterpermits the passage of a scope which is commonly used in Lithotripsy. Inone embodiment, the lumen may have a diameter in the range of 3 to 8 mmor 8 to 24 French. The sheath 20 may include markings on the outersurface 24 of the sheath which may aid in determining the position ofthe sheath within a patient based on distance. A radio-opaque materialmay also be used on the outer surface 24 of the sheath to aid indetermining the position of the sheath within a patient. In oneembodiment of the present invention, the distal end 22 of sheath 20 ismade of expandable material. Once the distal end is inserted into apatient's body cavity or lumen it can be expanded by an expansionballoon, an expansion spring, or some another mechanism. The expandeddistal end 22 can then be used to entrap the stone, foreign body, tissueor targeted organ inside sheath for treatment. In yet anotherembodiment, the distal end 22 of sheath 20 is constructed in a taperedconfiguration to facilitate the insertion of the said sheath into thepatient's body cavity and lumen. Once the distal end 22 of sheath 20 isin place, the distal end 22 can then be expanded as needed.

The proximal sheath 30 has a proximal end 31 and a distal end 32. Theproximal sheath 30 also includes a lumen 33 through which tools,instruments, stones and foreign bodies pass and an outer surface 34. Theproximal sheath 30 is transparent or semi-transparent so that the stonefragments can be visualized as they travel up the lumen 33 and exit theside arm 50. The proximal sheath 30 has a connection fitting to receivea flexible cap 100. One embodiment of the present invention uses a hatlike connecting joint. The proximal sheath 30 also has a connectionmechanism 35 that allows for a secure connection between the proximalsheath 30 and the obturator 90. This connection will prevent separationof obturator 90 from the proximal sheath 30 during the insertion into apatient's body luminal cavity. This connection can be constructed invarious shapes or types and includes a simple male to female screw-onconnection. In one embodiment of the present invention, the female endof the connection is on the proximal end 31 of the proximal sheath 30.The length of the proximal sheath 30 may be in the range of 4 to 8 cm.The outer surface 34 of the proximal sheath 30 has one or more side arms50, at least one of which is the accessory side arm 60.

The side arm 50 emanates up from the outer surface 34 of the proximalsheath 30 and forms an angle with the proximal sheath 30 in the rangeof >0° to <180°, between 10° and 170°, between 20° and 160°, between 30°and 150°, between 20° and 110°, between 20° and 90°, or between 20° and70°. In one embodiment, the angle is 45° toward the proximal end 31 ofthe proximal sheath 30. In another embodiment, the angle is 30° towardthe proximal end 31 of the proximal sheath 30. In still anotherembodiment, the angle is 25° toward the proximal end 31 of the proximalsheath 30. In one embodiment, the diameter of the lumen 53 of the sidearm 50 is up to 20% smaller than the diameter of the lumen 33, 43 of theproximal 30 and the distal sheath 40. In another embodiment, thediameter of the lumen 53 of the side arm 50 has a diameter which is thesame or up to 20% larger than the diameter of the lumen 33, 43 of theproximal 30 and the distal sheath 40. In yet another embodiment, thediameter of the lumen 53 of the side arm 50 is the same or larger thanthe diameter of the lumen of the sheath 23, 33, 43 to facilitate theefficient evacuation of stones, stone fragments or other foreign bodies.Each side arm 50 includes a proximal end 51 and a distal end 52 with thedistal end 52 being secured to the outer surface 34 of the proximalsheath 30. The side arm 50 may also include a pressure regulatingmechanism 110. The pressure regulating mechanism 110 may simply be acontrol vent in the form of a slit or a hole, or it may be a moreelaborate mechanism such as a valve. In one embodiment of the presentinvention, a side arm 50 has a pressure regulating mechanism 110 in theform of a longitudinal slit in respect to the axis of the side arm 50and acts as a control vent. When minimum negative pressure is required,the slit is left open or minimally occluded. When more negative pressureis required the slit is further occluded as needed to a maximum ofcomplete closure. In another embodiment the pressure regulatingmechanism 110 is placed on the egress tubing (connecting to the negativepressure system 120) in the form of a three way valve. Additionally, theegress tubing has two perpendicular sluices; the second sluice can beused to clear blood clots, tissue fragments, or stone fragments thatmight have been aspirated into the egress tubing and cause blockage. Inanother embodiment, a rubber or silicone seal is attached to the sidearm 50. This seal can be used to close the control vent and relieve theoperator from the burden of manually closing the control vent. In yetanother embodiment, a push-pull mechanism is employed to close and openthe control vent instead of having the operator manually close thecontrol vent. Furthermore, the pressure regulating mechanism 110 can beplaced anywhere along the egress path (i.e. the side arm 50, theconnecting tubing 70, the collection container 80 or even on theaspirator (negative pressure system).

The proximal end 51 of the side arm 50 is configured to accept aconnection to a flexible tubing 70. The proximal end 51 can be straight,flared, tapered, expandable, and/or ribbed and/or have a luer lock orsome other type connector which may be used in conjunction with avariety of medical instruments known in the art which include, but arenot limited to, a wire basket retriever, a guide wire, a stylet, a loop,a grasper, or the like. A backflow preventer may also be associated withthe proximal end 51 of the accessory side arm. In one embodiment, theproximal end 51 is straight to avoid compromising the lumen 53 of theside arm 50 and thus reduce the efficiency of stone removal. In anotherembodiment, a marking is placed just proximal to the connection of theside arm 50 and the outer surface 34 of the proximal sheath 30. Thismarking can be seen both endoscopically and/or externally. The markingmay be any color or material which may be easily visualized by the userof the suction evacuation assembly 10. In one embodiment, the side arm50 further comprises a pressure regulating mechanism 110 which allows aperson using the suction evacuation assembly 10 and to increase ordecrease the negative pressure within the suction evacuation assembly.

In one embodiment of the present invention the proximal 30 and distalsheath 40 can be separated from one another. The distal sheath 40 isconstructed with a peelable (tearable) material. This can also beachieved with a fabricated perforation along the longitudinal axis ofthe distal sheath 40. In a preferred embodiment, there are two lateralwings placed at the proximal ends of the distal sheath 40. This willfacilitate the separation (peeling, tearing). In another embodiment thedistal sheath 40 can be expanded. This can be achieved with an expansionballoon, an expansion spring, or some other mechanical means. Theexpansion can achieve two effects:

(1) Dilate the space where the distal sheath 40 traverses, and

(2) Entrap the target within the distal sheath 40 for fragmentation,morcellation, ablation, or extraction.

In one embodiment of the present invention, the proximal sheath 30 has asecond side arm (sluice) which is an accessory side arm 60. Theaccessory side arm 60 is generally used for additional irrigation orpassage of a guide wire, stone basket or any other devices which may beneeded during a foreign body removal procedure. It may also be used asan additional channel for the stone or foreign body evacuation. Thesecond side arm may be located anywhere on the outer surface 34 of theproximal sheath. The accessory side arm 60 emanates up from the outersurface 34 of the proximal sheath 30 and forms an angle with theproximal sheath 30 in the range of >0° to <180°, between 10° and 170°,between 20° and 160°, between 30° and 150°, between 20° and 110°,between 20° and 90°, or between 20° and 70°. In one embodiment, theangle is 45° toward the proximal end 31 of the proximal sheath 30. Inanother embodiment, the angle is 30° toward the proximal end 31 of theproximal sheath 30. In still another embodiment, the angle is 25° towardthe proximal end 31 of the proximal sheath 30. In one embodiment, thediameter of the lumen 63 of the accessory side arm 60 is up to 20%smaller than the diameter of the lumen 33, 43 of the proximal 30 and thedistal sheath 40. In another embodiment, the diameter of the lumen 63 ofthe accessory side arm 60 has a diameter which is the same or up to 20%larger than the diameter of the lumen 33, 43 of the proximal 30 and thedistal sheath 40. In yet another embodiment, the diameter of the lumen63 of the accessory side arm 60 is the same or larger than the diameterof the lumen of the sheath 23, 33, 43 to facilitate the efficientevacuation of stones, stone fragments or other foreign bodies. Eachaccessory side arm 60 includes a proximal end 61 and a distal end 62with the distal end 62 being secured to the outer surface 34 of theproximal sheath 30. The accessory side arm 60 may also include apressure regulating mechanism 110. The pressure regulating mechanism 110may simply be a control vent in the form of a slit or a hole, or it maybe a more elaborate mechanism such as a valve. In one embodiment of thepresent invention, an accessory side arm 60 has a pressure regulatingmechanism 110 in the form of a longitudinal slit in respect to the axisof the accessory side arm 60 and acts as a control vent. When minimumnegative pressure is required, the slit is left open or minimallyoccluded. When more negative pressure is required the slit is furtheroccluded as needed to a maximum of complete closure. In one embodimentof the present invention, the proximal end 61 of the accessory side arm60 has two openings 88, 89 at a 90° angle to one another and each has aluer lock connection mechanism.

The distal sheath 40 has a proximal end and a distal end. The distalsheath 40 also includes a lumen 43 through which tools, instruments,stones and foreign bodies pass, an outer surface 44 and a lock 45 whichis used to connect the proximal sheath 30 and the distal sheath 40together and maintain the connection for as long as desired.Alternatively the distal sheath 40 and the proximal sheath 30 can beconstructed as a single piece in a straight or in arm over sleeve typeconfiguration. The distal sheath can be straight, tapered, expandable,or flared. The distal end of the distal sheath can be flat, beveled,convex, or concave. The preferred embodiment is a straight distal sheathwith a flat end. The distal end may be coated with hydrophilic coatingand/or polytetrafluoroethylene to reduce friction especially in a fluidenvironment. The distal sheath can be opaque, semi-transparent,transparent, or a combination of these. In the preferred embodiment, thedistal sheath is opaque to avoid reflection of illuminating light ofendoscope. The distal sheath may also have measurement markings toindicate the length of distal sheath has been advanced into the bodycavity. The length of the distal sheath 40 may be in the range of 15 to45 cm.

In one embodiment of the above method, the side arm 50 and/or theaccessory side arm 60 emanate from the outer surface 34 of the proximalsheath 30 at an angle of between 20° and 80° toward the proximal end 31of the sheath. In another embodiment, the above methods may furthercomprise the step of introducing a guide wire into a lumen or cavity ofa patient's body containing one or more stones or foreign bodies priorto inserting the sheath 20 into a lumen or cavity of a patient's body inorder to aid in the positioning the distal end 22 of the sheath in aposition in close proximity to the stones or foreign bodies. In yetanother embodiment, the above methods may further comprise the step ofvisualizing one or more stones and/or foreign objects which are toolarge to pass though the space between the scope and the inside surfaceof the sheath 20, but small enough to pass through the lumen 23 of thesheath, retracting the scope from the distal end 22 of the sheath to apoint which is just proximal to the location within the proximal sheath30 In yet another embodiment, the above method may further comprise thestep of where the side arm 50 emanates from the proximal sheath whilevisualizing the aspiration of the one or more stones and/or foreignobjects up the sheath and into the side arm and collecting the stone,foreign body and/or fragments in the collection container 80. In stillanother embodiment, the scope has a diameter which is smaller (at least20% smaller) than an inner diameter of the sheath of the suctionevacuation assembly resulting in an open channel within the lumen 23 ofthe sheath which permits the passage of stones, pieces of stones orother foreign objects through the lumen 23 of the sheath and through theone or more side arms (50, 53, 60, 63).

In one embodiment of the present invention, the above methods mayfurther comprise the step of providing a sheath 20 that is comprised ofa proximal sheath 30 and a distal sheath 40, the proximal sheath 30having a proximal end 31 and a distal end 32 and the distal sheath 40having a proximal end 41 and a distal end 42, wherein the distal end 32of the proximal sheath is secured to the proximal end 41 of the distalsheath and wherein the proximal sheath 30 has a primary side arm 50emanating from the outer surface 34 of the proximal sheath and asecondary (accessory) side arm 60 emanating from the outer surface 34 ofthe proximal sheath with the accessory side arm 60 providing anadditional access point for irrigation, a catheter, a guide wire, aforeign body basket, a back stop, or other instrument or device to bepassed through the sheath 20 anytime during the procedure to improve theefficacy of the procedure and the accessory will side arm 60 furthercomprising one or more sluices to allow the passage of any combinationof the above mentioned instruments.

In another embodiment of the present invention, the above methods mayfurther comprise the step of steps of introducing a guide wire into alumen or cavity of a patient's body containing one or more stones orforeign bodies prior to inserting the sheath 20 into a lumen or cavityof a patient's body in order to aid in the positioning the distal end 22of the sheath in a position in close proximity to the stones or foreignbodies, providing a secondary sheath 130 (See FIGS. 18 and 19) securedto the outer surface 24 of the sheath 20, now a primary sheath, passingthe guide wire through the secondary sheath 130 while positioning thedistal end 22 of the primary sheath in a position in close proximity tothe stones or foreign bodies. In still another embodiment of the abovemethods, the secondary sheath 130 may be used to guide additionalirrigation, a catheter, a foreign body basket, a backstop, an instrumentor device to the position in close proximity to the stones or foreignbodies simultaneously with the scope and/or irrigation, catheter,foreign body basket, backstop, instrument or device through the primarysheath 20. In yet another embodiment of the above methods, the secondarysheath 130 has a proximal end 131 which is located near the proximal end21 of the primary sheath and a distal end 132 which extends beyond thedistal end 22 of the primary sheath in order to allow irrigation, acatheter, a foreign body basket, a backstop, an instrument or device tobe passed beyond a stone, a stone fragment or other foreign body duringa procedure to remove or perform Lithotripsy on them.

In yet another embodiment, the distal sheath 40 is formed by twoconcentric sheaths, one larger and one smaller. The lumen of the largersheath is contiguous with the distal end 32 of the proximal sheath andthe lumen 63 of the first side arm 50. The lumen 133 of the secondarysheath is smaller and is contiguous with the lumen 63 of the second sidearm 60. In essence this configuration forms two separate chambers forthe main tube. In still another embodiment, the distal end of thesecondary sheath 130 (the smaller concentric tube) protrudes for somedistance beyond the primary sheath 20 (the larger concentric tube). Thedistance is about 1 cm, 2 cm 3 cm or less than 5 cm. In yet anotherembodiment, the distal sheath 40 is made of more than two concentrictubes in various configurations. The proximal sheath 30 and distalsheath 40 may be constructed of the same or different materials andrigidity. In one embodiment of the present invention, the proximalsheath 30 is rigid and constructed of polypropylene, polycarbonate, orpolyvinyl chloride while the distal sheath 40 is semi-rigid and isconstructed of nylon, polyethylene, or fluorinated ethylene propylene.

Tables 1 through 5 below describe several embodiments for surgeryinstruments known in the art:

TABLE 1 Super-Mini Percutaneous Nephroscope Assembly Sheath Length:Distal Length 13 CM plus 1 CM insertion Length Proximal Length 6.5 CMSizes: Range: 3-8 mm 10 French (Fr.) 3.3 mm 12 Fr., 4.0 mm 14 Fr., 4.7mm 16 Fr., 5.3 mm 18 Fr., 6.0 mm 22 Fr. 7.3 mm

TABLE 2 Nephroscope Length: 26-33 CM Sizes: 7.5 Fr. with Working Channel(2.5 mm) 9.0 Fr. with Working Channel (3.0 mm) 11.5 Fr. with WorkingChannel (3.85 mm)

TABLE 3 Super-Mini Cysto-Ureteroscope Assembly Sheath Length: ForBladder and Distal Ureter: Distal Length 18-24 (male-female) CM MidUreter: Distal Length 25 CM Proximal Length 6.5 CM

TABLE 4 Cysto-Ureteroscope Length: 33 CM Sizes: 7.5 Fr. with WorkingChannel (2.5 mm) 9.0 Fr. with Working Channel (3.0 mm) 11.5 Fr. withWorking Channel (3.85 mm)

TABLE 5 Ureteral Sheath: Distal Length: 43.5 CM plus a 5 MM InsertionLength 38.5 CM plus a 5 MM Insertion Length 32.5 CM plus a 5 MMInsertion Length 26.5 CM plus a 5 MM Insertion Length Proximal Length:5.5 CM Sizes: 12 Fr. ID (4.0 mm) and 14 Fr. OD (4.7 mm) 11.2 Fr. ID (3.7mm) with 2.8 Fr. Coaxial Channel (1 mm) and 15 Fr. OD (5.0 mm)(ID—Inside Diameter/OD—Outside Diameter)

Obturator 90, as used herein, refers to an instrument which is known inthe laparoscopic art. The obturator 90 is made of rigid, semi-rigid, orflexible material and may have a shaft 95 with an outer surface 94 whichis either written or smooth in texture. It may have a solid or hollowcenter. The obturator 90 has a proximal end 91 and a distal end 92 whichis inserted into the lumen 23, 33 sheath 24 proximal sheath 30. Thedistal end 92 may be straight, round, tapered, or beveled. The obturator90 is to fit snuggly in the sheath 20. In one embodiment of the presentinvention, the obturator 90 has a hollow center creating a lumen 93 anda tapered distal end 92 and a guide wire may be passed through the lumen93. In another embodiment, the obturator 90 is solid and the distal end92 in beveled. The proximal end 91 of the obturator may be constructedas a handle for easy grasping and with a luer lock mechanism to allowfor the attachment of an injection syringe. One embodiment may include aconnection mechanism at distal end 92 of the obturator located at theinterface between the obturator and the proximal end 21 of the sheath20. In another embodiment the obturator 90 includes a male to femaletype screw on connector which allows the obturator 90 to be engaged tothe proximal end of the proximal sheath after insertion into theproximal sheath after which the screw on connector may be disengaged andthe obturator 90 withdrawn from the lumen 23 of the sheath. In stillanother embodiment the connection is made by twisting a luer lockmechanism of the obturator and the sheath. This will prevent thedisengagement of the sheath from the obturator during the passage of thesheath through the body.

Flexible cap, as used herein, refers to a device which is constructed tofit the proximal end 21 of the sheath 20. The center opening may beself-sealing and the cap may be comprised of rubber, silicone, or anymaterial known to be acceptable in the art.

Connecting tubing 70 is well known in the art. Connecting tubing 70 canbe rigid, semi-rigid, or flexible tube of any medical grade material.Each piece of tubing as a proximal end 71 and a distal end 72, a lumen73 through which material may travel and an outer surface. In oneembodiment, the tubing is made of a clear PVC tubing. The tubing is usedto connect a side arm 50, an accessory side arm 60, or any part thereofto either a collection container 80, a negative pressure system 120, orany other device known in the art. In one embodiment of the presentinvention, a primary tube 76 is connected by one end to a side arm 50 oran accessory side arm 60 and connected at the opposite end to an ingressopening 82 on a collection container 80 and a secondary tube 78 isconnected by one end to an egress opening 83 on a collection container80 and connected at the opposite end to a negative pressure system 120.

Collection container 80 is a container of any shape. It has a cap 81 anda bottom. The cap has an ingress (intake) opening 82 into and an egress(outflow) opening 83. The ingress opening 82 may or may not have a oneway valve to prevent regurgitation of fluid and other materials into theconnecting tubing 70. The egress opening 83 or anywhere along the egresstubing may be fitted with a sieve like mechanism to prevent the outflowof small stone or foreign body fragments or other materials from thecollection container 80. The ingress opening has a connecting mechanismfor connection to the connecting tubing 70. The egress channel hasconnecting mechanism to connect to a standard negative pressureaspiration machine. The bottom of the collection container 80 maycontain a screw on or pull tab mechanism for the removal of specimenfrom the collection container 80. In one embodiment, the ingress tubing82 is a longer, rigid tube which extends deeper into the collectioncontainer 80 while the egress tubing 83 is a shorter, rigid tube with asieve 85 at the end that is inside the collection container. The bottomof the collection container has a pull tab for removal of collectedspecimens. In another embodiment, the egress tubing 83 is fitted with aside arm having a three-way valve 86 (FIGS. 10 and 17). The straight arm88 is connected to the negative pressure system 120 while the rightangle arm 89 is connected to a syringe. In normal operation the rightangle side arm is closed. However, when there are stone fragments, bloodclots, or tissue fragments obstructing the egress tubing 83, the rightangle port can be opened to clear the obstructing objects by usingirrigation with the attached syringe.

The instant invention also includes a device for removing a stone, astone fragment, a foreign body, or tissue fragment from a patientcomprising: a suction evacuation assembly 10 which includes a sheath 20and one or more side arms 50, an obturator 90 which is inserted into aproximal end 21 of the sheath and which extends beyond the distal end 22of the sheath and is releasably secured to the proximal end of thesheath, where the sheath is comprised of a proximal sheath 30 and adistal sheath 40, the proximal sheath 30 having a proximal end 31 and adistal end 32 and the distal sheath 40 having a proximal end 41 and adistal end 42 and wherein the distal end 32 of the proximal sheath issecured to the proximal end 41of the distal sheath. A side arm 50emanates from the outer surface 34 of the proximal sheath and anaccessory side arm 60 emanates from the outer surface 34 of the proximalsheath where the proximal sheath 30 and the distal sheath 40 each have alumen (33, 43 respectively) which is the same diameter as the lumen ofthe side arm 53 and as a lumen of the accessory side arm 63. A flexiblecap 100 is releasably secured to the proximal end 21 of the sheath and aproximal end of a primary tube 71 is releasably secured to the proximalend 61 of the accessory side arm and the distal end of the primary tubeis releasably secured to an ingress opening 82 of a collection container80. A proximal end of a secondary tube 78 is releasably secured to thecollection container 80 and a distal end of the secondary tube 78 isreleasably secured to a negative pressure system 120 where the obturator90 is withdrawn from the sheath 20 and a scope is inserted into thedistal end 21 of the sheath through the flexible cap 100 and into thepatient in order to visualize the stone or foreign body using the scope.The negative pressure system 120 is activated in order to remove thestone, foreign body, or tissue fragment from the cavity if a diameter ofthe stone, foreign body, or tissue fragment is narrower than an insidediameter of the sheath (lumen 23) and the side arm, orlithotripsy/ablation/morcellation is performed on the objects in orderto create fragments with a decreased diameter which allow the passage ofthe fragments within the inside diameter of the sheath (lumen 23) andthe lumen 53 of the side arm and/or accessory side arm 60. If the scopeis withdrawn to the marking band 36, this would further open up theegress channel to allow unimpeded movement of the objects. The stone,foreign body and/or tissue fragments are collected in the collectioncontainer 80. Lithotripsy can be accomplished with any of the currentavailable lithotripters: mechanical or electromechanical (the pneumaticlithotripter), electrohydraulic, ultrasonic, or laser. Tissue ablationcan be accomplished with any currently available thermal energy device.Tissue morcellation is generally achieved with currently availablemechanical morcellator.

In one embodiment of the above device, the side arm 50 and the accessoryside arm 60 each emanate from the outer sheath 34 of the proximal sheathat an angle of between 20° and 80° toward the proximal end 31 of thesheath. In another embodiment, a guide wire which is introduced into alumen or cavity of a patient's body containing one or more stones,foreign bodies or targeted tissue/organ prior to inserting the sheath20, 40 into a lumen or cavity of a patient's body in order to aid in thepositioning the distal end 22, 42 of the sheath in a position in closeproximity to the stones or foreign bodies. In still another embodiment,the side arm 50 and the accessory side arm 60 each further comprises apressure regulating mechanism which allows a person using the suctionevacuation assembly 10 to increase or decrease the negative pressurewithin the suction evacuation assembly. In yet another embodiment thescope has a diameter which is smaller than an inner diameter of thesheath 20, 30, 40 of the suction evacuation assembly 10 resulting in anopen channel within the lumen 23, 33, 43 of the sheath which permits thepassage of stones, pieces of stones or other foreign objects through thelumen of the sheath and through the side arm 50 and/or accessory sidearm 60.

In one embodiment of the present invention, the suction evacuationassembly 10 further comprises a secondary sheath 130 secured to theouter surface 24 of the sheath, now a primary sheath. The secondarysheath 130 allows the passage of a guide wire through the lumen 133 ofthe secondary sheath while positioning the distal end 22 of the primarysheath in a position in close proximity to the stones or foreign bodies.In another embodiment, the secondary sheath 130 may be used to guideadditional irrigation, a catheter, a foreign body basket, a backstop, aninstrument or device to the position in close proximity to the stones orforeign bodies simultaneously with the scope and/or irrigation,catheter, foreign body basket, backstop, instrument or device throughthe primary sheath. In yet another embodiment, the secondary sheath 130has a proximal end 131 which is located near the proximal end 21 of theprimary sheath and a distal end 132 which extends beyond the distal end22 of the primary sheath in order to allow irrigation, a catheter, aforeign body basket, a backstop, an instrument or device to be passedbeyond a stone, a stone fragment or other foreign body during aprocedure to remove them.

The suction evacuation assembly 10 may include a flexible cap 100 whichis designed to engage an actuation device. An actuation device mayinclude a handle and an actuator which is engaged with a cable. Thecable then passes through the flexible cap 100 and is then slidablydisposed within the lumen 23 of a sheath. In one embodiment of thepresent invention, a wire basket retriever is located on the distal endof a cable. The proximal end of the cable is releasably engaged to anactuator within the handle of an actuation device. The actuation devicemay include any device known in the art. An operator may hold the handleand operate the actuator in a slidable manner moving the actuator in aproximal and distal direction relative to the flexible cap 100.

The suction evacuation assembly 10 may also include additional tools andattachments which aid in the extraction of one or more stones or otherforeign bodies from a patient. Each of the tools mentioned herein may beinserted into the proximal end of a sheath 20, side arm 54 or accessoryside arm 60 and fed into the lumen 23, 43 or 53 in a slideable manneruntil reaching the distal end 22 of the sheath. The tools may then belocked in place, actuated with the aid of an actuation device,manipulated by an individual (i.e. a physician, nurse, surgicaltechnician, etc.), or utilized in any manner known in the art.

In one embodiment of the present invention, the suction evacuationassembly 10 may further include a wire basket retriever (notillustrated) which is used to collect and extract stones from a patient.The wire basket retriever may be made up of two or more wires whichallow the wire basket to envelop an object (i.e. a stone) to either holdit in place or extract it.

In yet another embodiment, the suction evacuation assembly 10 mayfurther include a loop 100 (not illustrated) to aid in the removal ofstones or other undesirable materials or tissues. The loop may beelectrified to permit the cautery removal of tissues such as polyps(i.e. a polypectomy loop). A loop may be either permanently ortemporarily attached to a cable which may be either permanently ortemporarily attached to either a flexible cap 100 which may be engagedto the distal end of a side arm 50 or accessory side arm 60. In stillanother embodiment, the suction evacuation assembly 10 may furtherinclude a grasping tool (not illustrated) which would enable the user(i.e. a surgeon) to grasp and manipulate objects and/or tissues. Inanother embodiment of the present invention, all parts of the suctionevacuation assembly 10 in all tools and instruments associated with itare autoclaveable.

In one embodiment of the present invention the device can also be usedfor tissue ablation.

Methodology: The distal sheath 40 is advanced to the target organ eitherunder direct vision or through ultrasonic/radiological guidance with orwithout guide wire. An endoscope with tissue ablation instrument ispassed through the sheath 40. Tissue is ablated or morcellated, tissuefragments are evacuated between the space of the scope and the sheath oralternatively if the tissue fragments are too large to be evacuated fromthis space but small enough to enter the sheath, the scope can bewithdrawn to the bifurcation to allow unimpeded passage of the tissue.The accessory channel or channels can be used for additional irrigation,passage of guide wire, grasper, or any other devices or instruments.With the expandable distal sheath 40, the sheath can be advanced whiledilating the space/lumen. In addition and/or alternatively, the expandeddistal end 42 can be used to entrap the objective inside the shaft toperform fragmentation, ablation, morcellation, or extraction.

-   1. A method for removing a stone, a stone fragment or a foreign body    from a patient using a suction evacuation assembly comprising the    steps of:

providing a suction evacuation assembly which includes a sheath and oneor more side arms;

inserting an obturator into a proximal end of a sheath and securing saidobturator to the proximal end of said sheath;

said sheath being comprised of a proximal sheath and a distal sheath,said proximal sheath having a proximal end and a distal end and saiddistal sheath having a proximal end and a distal end;

-   -   wherein the distal end of said proximal sheath is secured to the        proximal end of said distal sheath and wherein said proximal        sheath has one or more side arms emanating from the outer        surface of said proximal sheath; and    -   wherein the sheath having a lumen which is the same diameter as        a lumen of said one or more side arms;

inserting a distal end of said sheath into a lumen or cavity of apatient's body containing one or more stones or foreign bodies;

positioning the distal end of said sheath in a position in closeproximity to said stones or foreign bodies;

disengaging said obturator from the proximal end of said sheath andremoving said obturator from said sheath;

securing a flexible cap to the proximal end of the sheath;

connecting one end of a primary tube to one of the side arms andconnecting the other end of said primary tube to a collection bottle;

connecting one end of a secondary tube to said collection bottle andconnecting the other end of said secondary tube to a negative pressuresystem;

inserting a scope into the sheath through the flexible cap and into saidpatient;

visualizing said stone or foreign body using said scope;

activating said negative pressure system in order to remove said stoneor foreign body from said cavity if a diameter of said stone or foreignbody is narrower than an inside diameter of said sheath and said sidearm, or

performing a lithotripsy on said stone or said foreign body in order tocreate fragments with a decreased diameter which allow the passage ofsaid fragments within the inside diameter of said sheath and said sidearm; and

collecting the stone, foreign body and/or fragments in said collectionbottle.

-   2. The method of claim 1 wherein said one or more side arms emanate    from the outer surface of said proximal sheath at an angle of    between 20° and 80° toward the proximal end of said sheath.-   3. The method of claim 1 further comprising the step of:

introducing a guide wire into a lumen or cavity of a patient's bodycontaining one or more stones or foreign bodies prior to inserting saidsheath into a lumen or cavity of a patient's body in order to aid in thepositioning the distal end of said sheath in a position in closeproximity to said stones or foreign bodies.

-   4. The method of claim 1 further comprising the step of:

visualizing one or more stones and/or foreign objects which are toolarge to pass though the space between the scope and the inside surfaceof the sheath, but small enough to pass through the lumen of the sheath;

retracting the scope from the distal end of the sheath to a point whichis just proximal to the location within the proximal sheath where saidside arm emanates from said proximal sheath while visualizing theaspiration of said one or more stones and/or foreign objects up thesheath and into said side arm; and

collecting the stone, foreign body and/or fragments in said collectioncontainer.

-   5. The method of claim 1 further comprising the steps of:

providing a sheath that is comprised of a proximal sheath and a distalsheath, said proximal sheath having a proximal end and a distal end andsaid distal sheath having a proximal end and a distal end;

-   -   wherein the distal end of said proximal sheath is secured to the        proximal end of said distal sheath and wherein said proximal        sheath has a primary side arm emanating from the outer surface        of said proximal sheath and a secondary side arm emanating from        the outer surface of said proximal sheath;        -   said second side arm providing an additional access point            for irrigation, a catheter, a guide wire, a foreign body            basket, a back stop, or other instrument or device to be            passed through the sheath anytime during the procedure to            improve the efficacy of the procedure; and        -   said second side arm further comprising one or more sluices            to allow the passage of any combination of the above            mentioned instruments.

-   6. The method of claim 1 wherein said one or more side arms further    comprises a pressure regulating mechanism which allows a person    using the suction evacuation assembly to increase or decrease the    negative pressure within the suction evacuation assembly.

-   7. The method of claim 1 wherein the scope has a diameter which is    smaller than an inner diameter of the sheath of the suction    evacuation assembly resulting in an open channel within the lumen of    the sheath which permits the passage of stones, pieces of stones or    other foreign objects through the lumen of the sheath and through    said one or more side arms.

-   8. The method of claim 1 further comprising the steps of:

introducing a guide wire into a lumen or cavity of a patient's bodycontaining one or more stones or foreign bodies prior to inserting saidsheath into a lumen or cavity of a patient's body in order to aid in thepositioning the distal end of said sheath in a position in closeproximity to said stones or foreign bodies;

-   -   providing a secondary sheath secured to the outer surface of the        sheath, now a primary sheath;    -   passing the guide wire through the secondary sheath while        positioning the distal end of said primary sheath in a position        in close proximity to said stones or foreign bodies.

-   9. The method of claim 8 wherein said secondary sheath may be used    to guide additional irrigation, a catheter, a foreign body basket, a    backstop, an instrument or device to the position in close proximity    to said stones or foreign bodies simultaneously with the scope    and/or irrigation, catheter, foreign body basket, backstop,    instrument or device through the primary sheath.

-   10. The method of claim 9 wherein said secondary sheath has a    proximal end which is located near the proximal end of the primary    sheath and a distal end which extends beyond the distal end of the    primary sheath in order to allow irrigation, a catheter, a foreign    body basket, a backstop, an instrument or device to be passed beyond    a stone, a stone fragment or other foreign body during a procedure    to remove them.

-   11. The method of claim 1 wherein, the method could also be used for    tissue ablation and morcellation

-   12. A device for removing a stone, a stone fragment or a foreign    body from a patient comprising:

a suction evacuation assembly which includes a sheath and one or moreside arms;

an obturator which is inserted into a proximal end of the sheath andwhich extends beyond the distal end of the sheath and releaseablysecured to the proximal end of said sheath;

said sheath being comprised of a proximal sheath and a distal sheath,said proximal sheath having a proximal end and a distal end and saiddistal sheath having a proximal end and a distal end;

-   -   wherein the distal end of said proximal sheath is secured to the        proximal end of said distal sheath;

a side arm emanating from the outer surface of said proximal sheath;

a accessory side arm emanating from the outer surface of said proximalsheath;

-   -   said sheath having a lumen which is the same diameter as a lumen        of said side arm and as a lumen of said accessory side arm;

a flexible cap releaseably secured to the proximal end of the sheath;

a proximal end of a primary tube releaseably secured to said accessoryside arm and a distal end of said primary tube releaseably secured to acollection container; and

a proximal end of a secondary tube releaseably secured to saidcollection container and a distal end of said secondary tube releaseablysecured to a negative pressure system;

-   -   wherein said obturator is withdrawn from said sheath and a scope        is inserted into the sheath through the flexible cap and into        said patient in order to visualize said stone or foreign body        using said scope;    -   the negative pressure system is activated in order to remove        said stone or foreign body from said cavity if a diameter of        said stone or foreign body is narrower than an inside diameter        of said sheath and said side arm, or    -   lithotripsy is performed on said stone or said foreign body in        order to create fragments with a decreased diameter which allow        the passage of said fragments within the inside diameter of said        sheath and said side arm; and    -   the stone, foreign body and/or fragments are collected in said        collection container.

-   13. The device of claim 12 wherein said side arm and said accessory    side arm each emanate from the outer sheath of said proximal sheath    at an angle of between 20° and 80° toward the proximal end of said    sheath.

-   14. The device of claim 12 further comprising:

a guide wire which is introduced into a lumen or cavity of a patient'sbody containing one or more stones or foreign bodies prior to insertingsaid sheath into a lumen or cavity of a patient's body in order to aidin the positioning the distal end of said sheath in a position in closeproximity to said stones or foreign bodies.

-   15. The device of claim 12 wherein said side arm and said accessory    side arm each further comprise a pressure regulating mechanism which    allows a person using the suction evacuation assembly to increase or    decrease the negative pressure within the suction evacuation    assembly.-   16. The device of claim 12 wherein the scope has a diameter which is    smaller than an inner diameter of the sheath of the suction    evacuation assembly resulting in an open channel within the lumen of    the sheath which permits the passage of stones, pieces of stones or    other foreign objects through the lumen of the sheath and through    said side arm and/or accessory side arm.-   17. The device of claim 12 wherein the suction evacuation assembly    further comprising:

a secondary sheath secured to the outer surface of the sheath, now aprimary sheath;

said secondary sheath allows the passage of a guide wire through thesecondary sheath while positioning the distal end of said primary sheathin a position in close proximity to said stones or foreign bodies.

-   18. The device of claim 17 wherein said secondary sheath may be used    to guide additional irrigation, a catheter, a foreign body basket, a    backstop, an instrument or device to the position in close proximity    to said stones or foreign bodies simultaneously with the scope    and/or irrigation, catheter, foreign body basket, backstop,    instrument or device through the primary sheath.-   19. The device of claim 18 wherein said secondary sheath has a    proximal end which is located near the proximal end of the primary    sheath and a distal end which extends beyond the distal end of the    primary sheath in order to allow irrigation, a catheter, a foreign    body basket, a backstop, an instrument or device to be passed beyond    a stone, a stone fragment or other foreign body during a procedure    to remove them.-   20. The device of claim 12 wherein the device is used for tissue    ablation and morcellation.

The present invention may be embodied in other forms without departingfrom the spirit and the essential attributes thereof, and, accordingly,reference should be made to the appended claims, rather than to theforegoing specification, as indicating the scope of the invention. Theinvention illustratively discloses herein suitably may be practiced inthe absence of any element which is not specifically disclosed herein.

I claim:
 1. A device for removing a stone, a stone fragment or a foreignbody from a patient comprising: a suction evacuation assembly whichincludes a sheath and at least one side arm; an obturator having astraight or tapered distal end which is inserted into a proximal end ofthe sheath and which extends beyond the distal end of the sheath and isreleasably secured to the proximal end of said sheath; said sheathhaving a proximal end and a distal end; the side arm emanating from theouter surface of said sheath, wherein said side arm further comprises apressure regulating mechanism in the form of a longitudinal slit inrespect of the axis of the side arm which allows a person using thesuction evacuation assembly to increase the negative pressure within thesuction evacuation assembly by covering the pressure regulatingmechanism or decrease the negative pressure within the suctionevacuation assembly by uncovering the pressure regulating mechanism; aflexible cap releasably secured to the proximal end of the sheath; aproximal end of a primary tube releasably secured to said side arm and adistal end of said primary tube releasably secured to a collectioncontainer; and a proximal end of a secondary tube releasably secured tosaid collection container and a distal end of said secondary tubereleasably secured to a negative pressure system; wherein said obturatorcan be withdrawn from said sheath and a scope can be inserted into thesheath through the flexible cap and into said patient in order tovisualize said stone or foreign body using said scope; and wherein thenegative pressure system can be activated in order to remove said stoneor foreign body from said cavity if a diameter of said stone or foreignbody is narrower than an inside diameter of said sheath and said sidearm, or lithotripsy can be performed on said stone or said foreign bodyin order to create fragments with a decreased diameter which allow thepassage of said fragments within the inside diameter of said sheath andsaid side arm; and the stone, foreign body and/or fragments can becollected in said collection container.
 2. The device of claim 1 furtherincluding a guide wire which can be introduced into a lumen or cavity ofa patient's body containing one or more stones or foreign bodies priorto inserting said sheath into a lumen or cavity of a patient's body inorder to aid in the positioning the distal end of said sheath in aposition in close proximity to said stones or foreign bodies; and aneedle assembly which includes a needle sheath with an inner channel andan outer surface and a needle shaft which are releasably secured to oneanother; wherein the needle shaft can be inserted into the needle sheathwhich can be inserted into the obturator which can then be inserted intothe suction-evacuation sheath allowing the guide wire to pass throughthe needle sheath while positioning the distal end of said sheath in aposition in close proximity to said stones or foreign bodies.
 3. Thedevice of claim 1 further comprising: a flexible, deflectable tipsecured to the distal end of the distal sheath which will enable theuser to adjust the direction of suction, irrigation, instrumentplacement, or removal of a stone, stone fragment or any other foreignbody or tissue from a patient; and an expandable distal sheath, aballoon that can be inflated to hold the sheath in place within the bodycavity or an anchoring mechanism operationally associated with thedistal portion of the distal shaft.
 4. The device of claim 1 furthercomprising an accessory side arm wherein said side arm and saidaccessory side arm each further comprise a pressure regulating mechanismwhich allows a person using the suction evacuation assembly to increaseor decrease the negative pressure within the suction evacuationassembly.
 5. The device of claim 1 wherein the scope has a diameterwhich is smaller than an inner diameter of the sheath of the suctionevacuation assembly resulting in an open channel within the lumen of thesheath which permits the passage of stones, pieces of stones or otherforeign objects through the lumen of the sheath and through said sidearm and/or accessory side arm.
 6. The device of claim 1 wherein thesuction evacuation assembly further comprises: a secondary sheathsecured to the outer surface of the sheath, now a primary sheath; saidsecondary sheath allows the passage of a guide wire through thesecondary sheath while positioning the distal end of said primary sheathin a position in close proximity to said stones or foreign bodies. 7.The device of claim 6 wherein said secondary sheath may be used to guideadditional irrigation, a catheter, a foreign body basket, a backstop, aninstrument or device to the position in close proximity to said stonesor foreign bodies simultaneously with the scope and/or irrigation,catheter, foreign body basket, backstop, instrument or device throughthe primary sheath.
 8. The device of claim 7 wherein said secondarysheath has a proximal end which is located near the proximal end of theprimary sheath and a distal end which extends beyond the distal end ofthe primary sheath in order to allow irrigation, a catheter, a foreignbody basket, a backstop, an instrument or device to be passed beyond astone, a stone fragment or other foreign body during a procedure toremove them.
 9. The device of claim 1 wherein the suction evacuationassembly further includes the addition of two, three or four barrelswhich are integral to the structure of the sheath and wherein theadditional barrels may be used to guide additional irrigation, acatheter, a foreign body basket, a backstop, an instrument or device tothe position in close proximity to said stones or foreign bodiessimultaneously with the scope and/or irrigation, catheter, foreign bodybasket, backstop, instrument or device through the primary sheath.
 10. Adevice for removing a stone, a stone fragment or a foreign body from apatient comprising: a suction evacuation assembly which includes asheath and at least one side arm; an obturator having a straight ortapered distal end which is inserted into a proximal end of the sheathand which extends beyond the distal end of the sheath and is releasablysecured to the proximal end of said sheath; said sheath having aproximal end and a distal end; the side arm emanating from the outersurface of said sheath, wherein said side arm further comprises apressure regulating mechanism in the form of a longitudinal slit inrespect of the axis of the side arm which allows a person using thesuction evacuation assembly to increase the negative pressure within thesuction evacuation assembly by covering the pressure regulatingmechanism or decrease the negative pressure within the suctionevacuation assembly by uncovering the pressure regulating mechanism; aflexible cap releasably secured to the proximal end of the sheath; aproximal end of a primary tube releasably secured to said accessory sidearm and a distal end of said primary tube releasably secured to acollection container; and a proximal end of a secondary tube releasablysecured to said collection container and a distal end of said secondarytube releasably secured to a negative pressure system; a second pressureregulating mechanism located near the distal end of said primary tube ornear the proximal end of said secondary tube which allows a person usingthe suction evacuation assembly to increase the negative pressure withinthe suction evacuation assembly by opening the second pressureregulating mechanism or decrease the negative pressure within thesuction evacuation assembly by closing the second pressure regulatingmechanism; wherein said obturator can be withdrawn from said sheath anda scope can be inserted into the sheath through the flexible cap andinto said patient in order to visualize said stone or foreign body usingsaid scope; and wherein the negative pressure system can be activated inorder to remove said stone or foreign body from said cavity if adiameter of said stone or foreign body is narrower than an insidediameter of said sheath and said side arm, or lithotripsy can beperformed on said stone or said foreign body in order to createfragments with a decreased diameter which allow the passage of saidfragments within the inside diameter of said sheath and said side arm;and the stone, foreign body and/or fragments can be collected in saidcollection container.
 11. The device of claim 10 further including aguide wire which can be introduced into a lumen or cavity of a patient'sbody containing one or more stones or foreign bodies prior to insertingsaid sheath into a lumen or cavity of a patient's body in order to aidin the positioning the distal end of said sheath in a position in closeproximity to said stones or foreign bodies; and a needle assembly whichincludes a needle sheath with an inner channel and an outer surface anda needle shaft which are releasably secured to one another; wherein theneedle shaft can be inserted into the needle sheath which can beinserted into the obturator which can then be inserted into thesuction-evacuation sheath allowing the guide wire to pass through theneedle sheath while positioning the distal end of said sheath in aposition in close proximity to said stones or foreign bodies.
 12. Thedevice of claim 10 further comprising: a flexible, deflectable tipsecured to the distal end of the distal sheath which will enable theuser to adjust the direction of suction, irrigation, instrumentplacement, or removal of a stone, stone fragment or any other foreignbody or tissue from a patient; and an expandable distal sheath, aballoon that can be inflated to hold the sheath in place within the bodycavity or an anchoring mechanism operationally associated with thedistal portion of the distal shaft.
 13. The device of claim 10 whereinsaid side arm and said accessory side arm each further comprise apressure regulating mechanism which allows a person using the suctionevacuation assembly to increase or decrease the negative pressure withinthe suction evacuation assembly.
 14. The device of claim 10 wherein thescope has a diameter which is smaller than an inner diameter of thesheath of the suction evacuation assembly resulting in an open channelwithin the lumen of the sheath which permits the passage of stones,pieces of stones or other foreign objects through the lumen of thesheath and through said side arm and/or accessory side arm.
 15. Thedevice of claim 10 wherein the suction evacuation assembly furthercomprises: a secondary sheath secured to the outer surface of thesheath, now a primary sheath; said secondary sheath allows the passageof a guide wire through the secondary sheath while positioning thedistal end of said primary sheath in a position in close proximity tosaid stones or foreign bodies.
 16. The device of claim 15 wherein saidsecondary sheath may be used to guide additional irrigation, a catheter,a foreign body basket, a backstop, an instrument or device to theposition in close proximity to said stones or foreign bodiessimultaneously with the scope and/or irrigation, catheter, foreign bodybasket, backstop, instrument or device through the primary sheath. 17.The device of claim 16 wherein said secondary sheath has a proximal endwhich is located near the proximal end of the primary sheath and adistal end which extends beyond the distal end of the primary sheath inorder to allow irrigation, a catheter, a foreign body basket, abackstop, an instrument or device to be passed beyond a stone, a stonefragment or other foreign body during a procedure to remove them. 18.The device of claim 10 wherein the suction evacuation assembly furtherincludes the addition of two, three or four barrels which are integralto the structure of the sheath and wherein the additional barrels may beused to guide additional irrigation, a catheter, a foreign body basket,a backstop, an instrument or device to the position in close proximityto said stones or foreign bodies simultaneously with the scope and/orirrigation, catheter, foreign body basket, backstop, instrument ordevice through the primary sheath.